Pharmaceutical composition containing silybin and ve

Abstract

A pharmaceutical composition is prepared from the following raw materials (in parts by weight): silybin (8.75-60), phospholipid (15-65), a Pu'er tea extract (25-200), and vitamin E (6.25-40). The composition has the effect of treating non-alcoholic fatty liver diseases.

The invention claimed is: 
     
       1. A pharmaceutical granule consisting essentially of bulk drugs, wherein the bulk drugs consist of
 8.75-60 parts by weight of silybin; 
 15-65 parts by weight of phospholipid; 
 25-200 parts by weight of Pu'er tea extract; and 
 6.25-40 parts by weight of vitamin E; and, 
 wherein the pharmaceutical granule consists of a first particle consisting of the Pu'er tea extract coated with a mixture of the phospholipid and the silybin, and additional particles consisting of the vitamin E, and, optionally, pharmaceutically acceptable carriers. 
 
     
     
       2. The pharmaceutical granule of  claim 1 , wherein the bulk drugs consist of
 25-40 by weight parts of silybin; 
 30-50 parts by weight of phospholipid; 
 80-120 parts by weight of Pu'er tea extract; and 
 20-30 parts by weight of vitamin E. 
 
     
     
       3. The pharmaceutical granule of  claim 1  wherein the vitamin E is vitamin E acetate. 
     
     
       4. The pharmaceutical granule of  claim 1 , wherein the pharmaceutically acceptable carriers are 0.1-99.9% of the total weight of the pharmaceutical granule. 
     
     
       5. The pharmaceutical granule of  claim 4 , wherein the pharmaceutically acceptable carriers are selected from the group consisting of mannitol, sorbitol, sorbic acid or sylvite, sodium metabisulfite, sodium bisulfite, sodium thiosulfate, cysteine hydrochloride, mercaptoacetic acid, methionine, vitamin A, vitamin C, vitamin D, 1-dodecylazacycloheptan-2-one, disodium EDTA, calcium disodium EDTA, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivative, cellulose and derivatives thereof, alginate, gelatin, polyvinyl pyrrolidone, glycerine, propylene glycol, ethanol, polysorbate 60-80, sorbitan monooleate, beeswax, lanolin, liquid paraffin, cetyl alcohol, gallic acid esters, agar, triethanolamine, basic amino acid, urea, allantoin, calcium carbonate, calcium bicarbonate, surfactant, polyethylene glycol, cyclodextrin, beta-cyclodextrin, kaolin, talc, calcium stearate, magnesium stearate, microcrystalline cellulose, and a carbonate, acetate, or phosphate salt of a monovalent alkali metal or aqueous solution thereof. 
     
     
       6. A dosage form comprising the pharmaceutical granule of  claim 4 , wherein the dosage form is selected from the group consisting of a tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, oral agent, granule, pill, powder, paste, sublimed preparation, suspensoid agent, solution, injection, suppository, ointment, emplastrum, creme, spray, and patch. 
     
     
       7. The pharmaceutical granule of  claim 2  wherein the vitamin E is vitamin E acetate or vitamin E succinate. 
     
     
       8. The pharmaceutical granule of  claim 1  wherein the vitamin E is vitamin E succinate. 
     
     
       9. The pharmaceutical granule of  claim 2 , wherein the pharmaceutically acceptable carriers are 0.1-99.9% of the total weight of the pharmaceutical composition. 
     
     
       10. The pharmaceutical granule of  claim 9 , wherein the pharmaceutically acceptable carriers are selected from the group consisting of mannitol, sorbitol, sorbic acid or sylvite, sodium metabisulfite, sodium bisulfite, sodium thiosulfate, cysteine hydrochloride, mercaptoacetic acid, methionine, vitamin A, vitamin C, vitamin D, 1-dodecylazacycloheptan-2-one, disodium EDTA, calcium disodium EDTA, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivative, cellulose and derivatives thereof, alginate, gelatin, polyvinyl pyrrolidone, glycerine, propylene glycol, ethanol, polysorbate 60-80, sorbitan monooleate, beeswax, lanolin, liquid paraffin, cetyl alcohol, gallic acid esters, agar, triethanolamine, basic amino acid, urea, allantoin, calcium carbonate, calcium bicarbonate, surfactant, polyethylene glycol, cyclodextrin, beta-cyclodextrin, kaolin, talc, calcium stearate, magnesium stearate, microcrystalline cellulose, and a carbonate, acetate, or phosphate salt of a monovalent alkali metal or aqueous solution thereof. 
     
     
       11. A dosage form comprising the pharmaceutical granule of  claim 9 , wherein the dosage form is selected from the group consisting of a tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, oral agent, granule, pill, powder, paste, sublimed preparation, suspensoid agent, solution, injection, suppository, ointment, emplastrum, creme, spray, and patch. 
     
     
       12. A pharmaceutical granule consisting essentially of bulk drugs, wherein the bulk drugs consist of
 6.3-17.3 parts by weight of silybin; 
 11-29 parts by weight of phospholipid; 
 40-73 parts by weight of Pu'er tea extract; and 
 7.7-20 parts by weight of vitamin E; and, 
 wherein the pharmaceutical granule consists of a first particle consisting of the Pu'er tea extract coated with a mixture of the phospholipid and the silybin, and additional particles consisting of the vitamin E, and, optionally, pharmaceutically acceptable carriers. 
 
     
     
       13. The pharmaceutical granule of  claim 12 , wherein the vitamin E is vitamin E acetate or vitamin E succinate. 
     
     
       14. The pharmaceutical granule of  claim 12 , wherein the pharmaceutically acceptable carriers are 0.1-99.9% of the total weight of the pharmaceutical composition. 
     
     
       15. The pharmaceutical granule of  claim 14 , wherein the pharmaceutically acceptable carriers are selected from the group consisting of mannitol, sorbitol, sorbic acid or sylvite, sodium metabisulfite, sodium bisulfite, sodium thiosulfate, cysteine hydrochloride, mercaptoacetic acid, methionine, vitamin A, vitamin C, vitamin D, 1-dodecylazacycloheptan-2-one, disodium EDTA, calcium disodium EDTA, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivative, cellulose and derivatives thereof, alginate, gelatin, polyvinyl pyrrolidone, glycerine, propylene glycol, ethanol, polysorbate 60-80, sorbitan monooleate, beeswax, lanolin, liquid paraffin, cetyl alcohol, gallic acid esters, agar, triethanolamine, basic amino acid, urea, allantoin, calcium carbonate, calcium bicarbonate, surfactant, polyethylene glycol, cyclodextrin, beta-cyclodextrin, kaolin, talc, calcium stearate, magnesium stearate, microcrystalline cellulose, and a carbonate, acetate, or phosphate salt of a monovalent alkali metal or aqueous solution thereof. 
     
     
       16. A dosage form comprising the pharmaceutical granule of  claim 14 , wherein the dosage form is selected from the group consisting of a tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, oral agent, granule, pill, powder, paste, sublimed preparation, suspensoid agent, solution, injection, suppository, ointment, emplastrum, creme, spray, and patch. 
     
     
       17. The pharmaceutical granule of  claim 12 , wherein the bulk drugs consist of
 14 parts by weight of silybin; 
 26 parts by weight of phospholipid; 
 40 parts by weight of Pu'er tea extract; and 
 20 parts by weight of vitamin E. 
 
     
     
       18. The pharmaceutical granule of  claim 17 , wherein the bulk drugs consist of
 105 mg of silybin; 
 195 mg of phospholipid; 
 300 mg of Pu'er tea extract; and 
 150 mg of vitamin E.